Product code LEI
- Device name
- Implant, Anti-Gastroesophageal Reflux
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- GU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P100049S041 | LINX Reflux Management System | Torax Medical | 2026-01-16 |
| P100049S040 | LINX™ Reflux Management System | Torax Medical | 2026-01-16 |
| P100049S038 | LINX Reflux Management System | Torax Medical | 2025-10-08 |
| P100049S037 | LINX Reflux Management System | Torax Medical | 2024-02-22 |
| P100049S036 | LINX Reflux Management System | Torax Medical | 2023-12-19 |
| P100049S035 | LINX Reflux Management System | Torax Medical | 2023-12-14 |
| P100049S033 | LINX Reflux Management System | Torax Medical | 2022-10-04 |
| P100049S029 | LINX Reflux Management System | Torax Medical | 2022-08-26 |
| P100049S034 | LINX Reflux Management System | Torax Medical | 2022-06-09 |
| P100049S032 | LINX Reflux Management System | Torax Medical | 2022-01-07 |
| P100049S031 | LINX Reflux Management System | Torax Medical | 2022-01-07 |
| P100049S030 | LINX Reflux Management System | Torax Medical | 2022-01-07 |
| P100049S027 | LINX Reflux Management System | Torax Medical | 2020-06-29 |
| P100049S028 | Linx Reflux Management System | Torax Medical | 2019-12-10 |
| P100049S026 | LINX Reflux Mnagement System | Torax Medical | 2019-07-15 |
| P100049S025 | LINX Reflux Management System | Torax Medical | 2018-11-09 |
| P100049S024 | LINX Reflux Management System | Torax Medical | 2018-10-16 |
| P100049S023 | LINX Reflux Management System | Torax Medical | 2018-09-06 |
| P100049S022 | LINX Reflux Management System | Torax Medical | 2018-07-23 |
| P100049S021 | Linx Reflux Management System | Torax Medical | 2018-03-15 |
| P100049S020 | Linx Reflux Management System | Torax Medical | 2018-01-29 |
| P100049S019 | LINX REFLUX MANAGEMENT SYSTEM | Torax Medical | 2017-01-12 |
| P100049S018 | LINX REFLUX MANAGEMENT SYSTEM, IMPLANT AND SIZING TOOL | Torax Medical | 2016-10-20 |
| P100049S017 | LINX REFLUX MANAGEMENT SYSTEM | Torax Medical | 2016-05-19 |
| P100049S016 | LINX REFLUX MANAGEMENT SYSTEM | Torax Medical | 2016-03-02 |
| P100049S015 | LINX REFLUX MANAGEMENT SYSTEM | Torax Medical | 2016-03-02 |
| P100049S014 | LINX REFLUX MANAGEMENT SYSTEM | Torax Medical | 2015-07-24 |
| P100049S013 | LINX REFLUX MANAGEMENT SYSTEM | Torax Medical | 2015-07-20 |
| P100049S012 | LINX REFLUX MANAGEMENT SYSTEM | Torax Medical | 2015-04-21 |
| P100049S011 | LINX REFLUX MANAGEMENT SYSTEM | Torax Medical | 2015-01-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00855106005370 | LINX | Torax Medical, Inc. | 2015-05-13 |
| 00855106005363 | LINX | Torax Medical, Inc. | 2015-05-13 |
| 00855106005356 | LINX | Torax Medical, Inc. | 2015-05-13 |
| 00855106005349 | LINX | Torax Medical, Inc. | 2015-05-13 |
| 00855106005332 | LINX | Torax Medical, Inc. | 2015-05-13 |
| 00855106005325 | LINX Reflux Management System | Torax Medical, Inc. | 2015-05-13 |
| 00855106005165 | LINX | Torax Medical, Inc. | 2014-09-10 |
| 00855106005226 | LINX Esophagus Sizing Tool | Torax Medical, Inc. | 2014-09-10 |
| 00855106005219 | LINX | Torax Medical, Inc. | 2014-09-10 |
| 00855106005158 | LINX | Torax Medical, Inc. | 2014-09-10 |
| 00855106005141 | LINX | Torax Medical, Inc. | 2014-09-10 |
| 00855106005134 | LINX | Torax Medical, Inc. | 2014-09-10 |
| 00855106005066 | LINX | Torax Medical, Inc. | 2014-09-10 |
| 00855106005059 | LINX | Torax Medical, Inc. | 2014-09-10 |
| 00855106005042 | LINX | Torax Medical, Inc. | 2014-09-10 |
| 00855106005035 | LINX | Torax Medical, Inc. | 2014-09-10 |
| 00855106005028 | LINX | Torax Medical, Inc. | 2014-09-10 |
| 00855106005011 | LINX | Torax Medical, Inc. | 2014-09-10 |
| 00855106005172 | LINX | Torax Medical, Inc. | 2014-09-09 |
| 00855106005189 | LINX | Torax Medical, Inc. | 2014-09-09 |